MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC PACEMAKER; DUAL CHAMBER TEMP PACEMAKER

Model Number 5388

Device Problem Loss of Power (1475)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762)

Event Date 05/20/2014

Event Type  malfunction  

Event Description

Pt with temporary pacemaker due to low hr in 30's.Temp pacer turned off without warning leaving the pt in asystole and requiring cpr.Device turned back on by nurse and pt hr increased back to prior setting.Again without waring the temp pacemaker turned off on its own.Device was exchanged and taken out of service.Diagnosis or reason for use: heart rate in 30's (bradycardia with symptoms).Event abated after use stopped or does reduced? yes.Event reappeared after reintroduction? yes.

• Brand Name: MEDTRONIC PACEMAKER
• Type of Device: DUAL CHAMBER TEMP PACEMAKER
• Manufacturer (Section D): MEDTRONIC; minneapolis MN
• MDR Report Key: 3874060
• MDR Text Key: 21720239
• Report Number: MW5036574
• Device Sequence Number: 1
• Product Code: DTE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5388
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 86